Class II · Moderate risk
Kabiven
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
FDA Drug Recalls
18,003 recalls, newest first
Class I · High risk
Adrucil (fluorouracil injection, USP)
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Class III · Low risk
Levalbuterol Inhalation Solution
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Class II · Moderate risk
Alinia (nitazoxanide)
Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
Class II · Moderate risk
Bi-Est (estriol,estradiol)
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Bi-Est (estriol,estradiol)
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Estradiol cream
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Bi-Est (estriol,estradiol)
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Estriol
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Bi-Est (estriol,estradiol)
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Estradiol
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Estradiol
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Tri-Est 80:10:10 Progesterone
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Methyl Folate Lyophilized Powder for Injection
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Artesunate Lyophilized Powder for Injection
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Meloxicam capsules
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Leucovorin Calcium capsules
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Bi-Est 80:20 Progesterone
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class I · High risk
Cytarabine Injection 100 mg/5 mL
Presence of Particulate Matter
Class I · High risk
Bupivacaine Hydrochloride Inj.
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Class II · Moderate risk
Ketorolac Trom 30 Mg/Ml Inj
Crystallization
Class II · Moderate risk
Captopril Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Captopril Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Captopril Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.